CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

CareSource utilization management policy assessing coverage/recommendation for Susvimo (ranibizumab intravitreal implant) for ophthalmology indications including neovascular (wet) AMD and diabetic macular edema (DME). It states the plan's position, safety concerns, and that approval is not recommended.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change Typeclarified

Effective Date

Next Review Date

Key ActionDo not submit authorization requests expecting approval; Susvimo is not recommended for approval for neovascular AMD, DME, or other circumstances due to boxed warning for endophthalmitis and increased ocular adverse events.

SourceLink

POLICY UPDATE CHANGES

Diabetic Macular Edema was added to the Conditions Not Recommended for Approval in selected revision dated 03/26/2025.

2Primary Conditions Listed as Not Recommended

Boxed WarningMajor Safety Concern

3-foldRelative increase in endophthalmitis rate (AMD)

Coverage Summary

Overview: This policy addresses coverage for Susvimo (ranibizumab intravitreal implant) for ophthalmology indications including neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME). The plan position is that approval of Susvimo is not recommended due to safety concerns, primarily a Boxed Warning for endophthalmitis and increased ocular adverse events. Last review: 2024-11-20.

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Policy Statement — Conditions Not Recommended for Approval

Policy Statement / Conditions Not Recommended for Approval

Due to safety concerns (boxed warning for endophthalmitis) approval of Susvimo is not recommended. Coverage of Susvimo is not recommended in the following situations:

Conditions Not Recommended for Approval

Neovascular (Wet) Age-Related Macular Degeneration (AMD): Approval is not recommended due to increased ocular adverse events and a boxed warning for endophthalmitis; in pivotal AMD trials Susvimo had a higher rate of endophthalmitis vs monthly intravitreal ranibizumab (1.7% vs 0.5% in active comparator period; 2% when including extension phases).
Patients treated with Susvimo require regular monitoring for implant- and procedure-related adverse events.
Diabetic Macular Edema (DME): Approval is not recommended due to safety concerns despite non-inferiority for efficacy in the pivotal DME trial; Susvimo labeling includes a boxed warning for endophthalmitis and higher ocular adverse events reported.
Other Circumstances: Any other circumstances not listed in Recommended Authorization Criteria: Coverage is not recommended.
Criteria will be updated as new published data are available.

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The product carries a Boxed Warning for endophthalmitis. In pivotal AMD trials Susvimo had a higher rate of endophthalmitis versus monthly intravitreal ranibizumab: 1.7% vs 0.5% in the active comparator period (about a three-fold increase), and 2% (11/555) when extension phases were included. In the DME program the extension-phase endophthalmitis rate with Susvimo was 0.7% (4/556).

Provider Actions

Denial Risk

Coverage Not Recommended

Do not submit authorization requests expecting approval; Susvimo is not recommended for approval for neovascular AMD, DME, or other circumstances due to boxed warning for endophthalmitis and increased ocular adverse events.

Documentation Required

Safety Monitoring Consideration (informational)

Patients treated with Susvimo require regular monitoring to evaluate for implant- and procedure-related adverse events (endophthalmitis, conjunctival erosion/retraction, implant dislocation, retinal detachment, vitreous hemorrhage).

Background & Evidence

Susvimo is an intravitreal implant formulation of ranibizumab indicated for neovascular (wet) AMD and DME in patients who previously responded to at least two intravitreal VEGF inhibitor injections. Unlike intravitreal injections, Susvimo is an implant and implant- or procedure-related risks include endophthalmitis (Boxed Warning), conjunctival erosion or retraction, implant dislocation, retinal detachment, vitreous hemorrhage, conjunctival bleb, postoperative decrease in visual acuity, and device filling/air bubble-related issues.

Finding	Value
Endophthalmitis rate in AMD active comparator period
Susvimo 1.7% vs intravitreal ranibizumab 0.5% (3-fold higher)
Endophthalmitis rate including extension phases (AMD)
2% (n=11/555) with Susvimo
Endophthalmitis rate including extension phases (DME)
0.7% (n=4/556) with Susvimo

Susvimo: Ranibizumab intravitreal injection delivered via an ocular implant for patients with neovascular AMD or DME who previously responded to at least two intravitreal VEGF inhibitor injections.